Brain, Growth & Development
Conditions
Brief summary
The overall objective is to characterize the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, in Chinese toddlers (32 to 42 months old).
Detailed description
The primary objective of this clinical study is to characterize in Chinese toddlers ages 32 - 42 months old the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, and to assess a range of executive functions (inhibit, shift, emotional control, working memory, plan/organize) using the Global Executive Composite summary score obtained from the BRIEF-P standardized rating scale.
Interventions
RADIATIONMRI
MRI is a safe, non-invasive, cutting edge imaging technology widely used to study the human brain both internationally (NIH connectome project) and in China (China Brain Project). The Baby Connectome Project (BCP) led by NIH scientists has begun data collection on the structural and functional brain development among American infants (Howell, Styner et al. 2019).
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
32 Months to 34 Months
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent has been obtained from the parent/legally acceptable representative. 2. Full-term birth (≥ 37 weeks and ≥ 2.5kg) 3. Typically developing Children aged between 32-34 months (2 years 8 months to 2 years10 month of age) at enrolment 4. Neurotypical development as assessed by interview 5. No major risk factors for learning, neurologic, or psychiatric disorder as assessed by interview \[defined as a diagnosed learning neurologic or psychiatric disorder in a first degree relative (e.g. parents, siblings)\]. 6. Dietary requirement detailed below: S-26 GOLD or ULTIMA GUM--fed group: I. Daily consumption of S-26 GOLD or ULTIMA GUM for the last 60 days (2 months) II. Desire of the parent to continue feeding GUM during the course of the study Cow's milk-fed group: I. Daily consumption of cow's milk or for the last 60 days (2 months) II. Desire of the parent to continue feeding cow's milk during the course of the study
Exclusion criteria
1. Delayed birth ( \> 41 weeks gestation) as reported in medical record 2. Birth Weight \< 2500 g or small for gestational age (birth weight below the 10th percentile) or large for gestational age (birth weight above the 90th percentile) as reported in medical record 3. History of neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in the toddler as assessed by interview 4. History of diagnosed neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in parents or siblings, as assessed by interview 5. In utero exposure to alcohol abuse or illicit substances as defined as diagnosis of current substance use disorder in the biological mother and guidelines set by the American College of Obstetricians and Gynecologists and the Royal College of Physicians 6. Multiple birth as reported in medical record 7. Complicated pregnancy (e.g., preeclampsia, gestational diabetes) as assessed by medical interview/ medical record 8. Abnormal screening laboratory values and studies considered to be clinically significant in the opinion of the Investigator (e.g., metabolic disease screening, neonatal bilirubin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neural flexibility | at baseline and 42 months after baseline | MRI-derived neural flexibility associated with cognitive flexibility (including anterior cingulate cortex, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, anterior insula, interior frontal junction, superior parietal lobule, precuneus, intraparietal sulcus, and temporoparietal junction) |
| Global Executive Composite (GEC) score | at baseline and 42 months of age | executive functions (inhibit, shift, emotional control, working memory, plan/organize) using the Global Executive Composite summary score obtained from the BRIEF-P standardized rating scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain function (network topologies) | at baseline and 42 months of age | Brain functional network topologies of the nine commonly assessed brain functional networks, including the primary visual, secondary visual, visual association, motosensory, default mode, frontoparietal, medial frontal, subcortical and cerebellum networks using MRI |
| Children development | at baseline and 42 months of age | Verbal Comprehension, Visual Spatial, Working Memory, and IQ using Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) |
| School readiness | at 42 months of age | Using Early Human Capability Index (eHCI) |
| Children behavior (for toddlers) | at baseline and 42 months of age | Using the Early Childhood Behavioral Questionnaire (ECBQ) |
| Sleep quality | at baseline and 42 months of age | Sleep quality, duration and efficiency (total sleep time / duration of sleep episode \*100) computed using the Brief Infant Sleep Questionnaire (BISQ). In addition, an actigraphy in combination with a sleep diary will be used during home period and their relationship will indicate the sleep quality |
| Home environment | at baseline and 8 months after baseline | Using validated Child Feeding Practice Questionnaire. In addition, to complete the feeding and adverse events calendar monthly during home period |
| Feeding practice | at baseline and 42 months of age | Using the Early Feeding Practice Questionnaire. In addition, the feeding and adverse events calendar monthly during home period |
| Fecal microbiota composition | at baseline and 42 months of age | Measured via the shotgun metagenomics sequencing for species composition and functional pathways through stool samples collected |
| Brain structure (brain regions volume) | at baseline and 42 months of age | Brain structure (brain regions volume) measured using MRI, including the hippocampal |
| Brain structure (cortical surface area) | at baseline and 42 months of age | Brain structure (cortical surface area) measured using MRI |
| Brain structure (cortical thickness) | at baseline and 42 months of age | Brain structure (cortical thickness) measured using MRI |
| Brain structure (myelination) | at baseline and 42 months of age | Brain structure (myelination) measured using MRI |
| Curiosity | at baseline and 42 months of age | Using the Curiosity Questionnaire |
| Brain function (connection strengths) | at baseline and 42 months of age | Brain functional connection strengths of the nine commonly assessed brain functional networks, including the primary visual, secondary visual, visual association, motosensory, default mode, frontoparietal, medial frontal, subcortical and cerebellum networks using MRI |
| Cognitive flexibility | at baseline and 42 months of age | Using the Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) parent-completed questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anthropometry (BMI) | at baseline and 42 months of age | Weight and height will be combined to report the BMI (kg/m2) and corresponding BMI-for-age Z-score according to the WHO growth standards |
| Adverse Events (e.g., type, incidence, severity, seriousness) | from enrollment until 42.5 months of age | standard AE reporting procedure |
| Gastrointestinal tolerance (for toddlers) | at baseline and 42 months of age | using the Toddler Gut Comfort Questionnaire (TGCQ) |
| Anthropometry (weight in grams) | at baseline and 42 months of age | Weight in grams and corresponding weight-for-age Z-score according to the WHO growth standards |
| Anthropometry (body length in centimeters) | at baseline and 42 months of age | Length in centimeters and corresponding length-for-age Z-score according to the WHO growth standards |
| Anthropometry (head circumference in centimeters) | at baseline and 42 months of age | Head circumference in centimeters and corresponding head-circumference-for-age Z-score according to the WHO growth standards |
| Anthropometry (weight-for-length) | at baseline and 42 months of age | Corresponding weight-for-length Z-score according to the WHO growth standards |
Countries
China
Contacts
Primary ContactJoyce Li
Outcome results
None listed